A group of trial lawyers representing a man who is suing GlaxoSmithKline and other pharmaceutical companies over claims that using Zantac had caused cancer, can't force the Journal of the American Medical Association to reveal the identity of a federal official - presumably at the Food and Drug Administration - who appeared to cajole JAMA into spiking the publication of an article on a study discussing a potential link between the Zantac drug and an elevated cancer risk.
On Oct. 27, a three-justice panel of the Illinois First District Appellate Court in Chicago reversed a ruling from a Cook County judge, who had determined that JAMA should be denied the ability to claim reporter's privilege under the law, to shield the man's lawyers from obtaining full copies of its communications with the official, identified only as "Government Official A," concerning the study.
In their ruling, the justices particularly expressed doubt that divesting JAMA of its so-called reporter's privilege would actually assist plaintiff Gibbons in his actual case against GSK and other associated defendants.
Matthew S. Sims
| rapoportlaw.com
The decision was authored by First District Appellate Justice Sanjay T. Tailor. Justices Mary L. Mikva and Carl A. Walker concurred in the opinion.
"... The FDA and other governmental agencies are not named as defendants in Gibbons's lawsuit, and his complaint does not allege any government misfeasance," the justices wrote in their opinion. "Thus, any alleged government misfeasance is a 'collateral matter' that is not directly relevant to Gibbons's claims that the pharmaceutical company defendants intentionally or negligently marketed a drug that caused cancer."
The decision centered on a subpoena action Nathan Gibbons and his lawyers launched against the Chicago-based JAMA in 2021.
Gibbons, like thousands of other plaintiffs across the country, had filed suit against GSK and other drugmaker and distributor defendants in the months after the FDA ordered the drug known as ranitidine removed from circulation in the U.S., over concerns the use of the medication could be associated with an increased cancer risk in those taking the medication.
Ranitidine, an anti-heartburn medication, was most commonly sold by GSK under the brand name Zantac.
However, months before the FDA moved to pull Zantac from shelves, a testing laboratory known as Valisure sent a so-called "citizen petition" to the FDA, calling on the federal agency to "recall and suspend sales" of the medication, indicating it believed Zantac contained high levels of a "probable human carcinogen," known as N-Nitrosodimethylamine, or NDMA.
In that petition, Valisure specifically cited work being conducted on the topic by researchers at Memorial Kettering Cancer Center in New York.
Valisure has generated controversy for years, as the work conducted by the laboratory has been used by trial lawyers across the country to launch sprawling mass tort actions against drug companies, in particular.
Valisure's testing methods have particularly been met with skepticism in court and elsewhere. In Florida last year, for instance, a federla judge dismissed thousands of lawsuits over Zantac, after ruling that Valisure's testing methods were unreliable.
According to published reports, some of Valisure's work has been funded by plaintiff's lawyers who then used the lab results to file lawsuits. Valisure notably shared details of the Zantac case with a Florida lawyer, who filed the first lawsuit over the alleged ranitidine cancer link the same day the FDA received Valisure's petition in 2019.
Meanwhile, state court judges in Delaware and California have put less stock in concerns over Valisure's testing methods, and have allowed tens of thousands of lawsuits, including Gibbons', to continue.
However, after filing suit in California, Gibbons' attorneys set their sights on JAMA in 2021, filing suit in Cook County Circuit Court, to demand details from JAMA on why it allegedly abruptly decided not to run a story on a study that could have backed Valisure's petition.
The study was authored by Lior Braunstein, an oncologist at Memorial Sloan Kettering Cancer Center, and "noted 'a possible association of ranitidine use with certain cancer presentations," which led the researchesrs to assert the FDA may have a "case for limiting ranitidine administration among patients."
According to the appellate opinion, Braunstein's manuscript passed peer review, and JAMA was allegedly about to publish the manuscript, when it allegedly abruptly changed its mind "at the eleventh hour."
Gibbons and his lawyers asserted in their filings that JAMA's decision was likely the result of pressure from either GSK and drugmakers, or from the FDA. They noted Braunstein's study utilized testing methods specifically rejected by the FDA.
JAMA then asked Braunstein to redo his study, using approved testing methods, and republish.
JAMA ultimately ran the revised version of Braunstein's work, though the new manuscript now did not expressly link Zantac to cancer.
Nonetheless, Valisure seized on the new article, to emphasize its own findings that "the potential carcinogenic nature of ranitidine are of high importance for public health and should be a part of the scientific and medical domain..."
In 2021, Gibbons and his lawyers, from the firms of Rapoport Weisberg & Sims, of Chicago, and Wisner Baum LLP, of Los Angeles, filed their action in Cook County court, demanding information from JAMA over why Braunstein's first manuscript was not published.
Evidence revealed that neither GSK nor any other drugmakers had direct communications with JAMA.
However, the evidence showed that a federal official had extensive conversations with the editors and other personnel at JAMA in the days preceding the decision to pull Braunstein's manuscript.
JAMA contested the subpoenas, asserting it should be protected by both "common law peer review privilege," and by reporter's privilege under Illinois law.
Cook County Judge Moira S. Johnson sided with Gibbons in the dispute, and directed JAMA to turn over their communications with the unidentified official, likely from the FDA, to Gibbons' lawyers.
On appeal, the First District justices agreed that JAMA could not be protected under the peer review privilege. They noted Gibbons' lawyers already knew the identity of the otherwise anonymous peer reviewers assigned to Braunstein's work.
However, the justices said JAMA can be protected under the reporter's privilege granted to journalists, protecting them from demands to turn over reporting notes and to reveal their sources in controversial or sensitive matters.
The justices noted that forcing JAMA to give plaintiffs' lawyers access to its internal communications would not advance their cause.
And the justices further noted Gibbons' case in support of his subpoena was further weakened by his refusal to submit a Freedom of Information Act request to the FDA, because his lawyers appeared to believe they would have easier access to the information through a subpoena case against JAMA, rather than waiting on the FDA to comply with FOIA.
"Although Gibbons asserts that 'the FDA would not even know where to begin' with his request, he was seeking a limited number of emails between 'Government Official A' and JAMA, and he even knew the dates the emails were sent, the times the emails were sent, and the subject lines for the emails," Justice Tailor wrote.
"This amount of specificity would provide the FDA with the information necessary to respond to his request....
"If Gibbons had sent an FOIA request to the FDA for the information he seeks and had been informed that the request would take years to produce (a position that we suspect would be viewed skeptically by any court given the detailed specificity of what Gibbons sought), we may have reached a different result. However, we note that 'the legislature intended divestiture of a reporter’s privilege to be the last resort to get the sought-after information.'
"Because Gibbons suspected it was the FDA that contacted JAMA with concerns about Dr. Braunstein’s article and because the FDA is the federal regulator of pharmaceutical drugs, we find he was required, under the statute, to attempt to obtain the information from that agency before seeking divestiture here."
JAMA was represented by attorneys Jack R. Bierig, Jonathan Judge, Catherine M. Masters and Max Heckendorn, of Arentfox Schiff LLP, of Chicago.
Gibbons is represented by attorneys Matthew S. Sims and Zartosht T. Khodavandi, of the Rapoport firm; and R. Brent Wisner, Adam M. Foster and Harrison E. James, of Wisner Baum.